FDA Review Panel · OB

FDA 510(k) Obstetrics & Gynecology Devices

FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview

FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.

Key categories:

  • Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
  • Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
  • Breast pumps and lactation aids - electric and manual breast pumps
  • Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
  • Pregnancy test systems - hCG detection devices for professional and home use

4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
1376–1400 of 4525
Cleared Dec 23, 2008
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
K081768 · Cook Incorporated
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 186d
Cleared Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K082677 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 99d
Cleared Dec 18, 2008
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
K080172 · Medicult A/S
MQL · Media, Reproductive · 329d
Cleared Dec 16, 2008
STRYKER VIDEOSCOPE
K082451 · Stryker Endoscopy
HET · Laparoscope, Gynecologic (and Accessories) · 113d
Cleared Dec 05, 2008
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · Bio Nuclear Diagnostics, Inc.
HHT · Spatula, Cervical, Cytological · 189d
Cleared Dec 04, 2008
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS
K082387 · American Medical Systems
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 107d
Cleared Nov 26, 2008
RAPIDVIT AND RAPIDWARM CLEAVE
K080446 · Vitrolife Sweden AB
MQL · Media, Reproductive · 281d
Cleared Nov 26, 2008
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 79d
Cleared Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
K082730 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 69d
Cleared Nov 21, 2008
JARIT HULKA UTERINE TENACULUM FORCEPS
K082349 · J. Jamner Surgical Instruments, Inc.
HDC · Tenaculum, Uterine · 98d
Cleared Nov 07, 2008
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · Cook Urological, Inc.
HFE · Brush, Endometrial · 108d
Cleared Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 81d
Cleared Oct 24, 2008
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
K081413 · Dailian Latex Company, Ltd.
HIS · Condom · 157d
Cleared Oct 15, 2008
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
K081710 · American Medical Systems
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 120d
Cleared Oct 10, 2008
VITRIFICATION KIT & VITRIFICATION WARMING KIT
K073522 · Sage In-Vitro Fertilization, Inc.
MQL · Media, Reproductive · 301d
Cleared Oct 09, 2008
URESTA PESSARY
K081385 · Eastmed, Inc.
HHW · Pessary, Vaginal · 146d
Cleared Oct 09, 2008
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
K082802 · Learning Curve Brands Inc. the First Years
HGX · Pump, Breast, Powered · 15d
Cleared Sep 30, 2008
AVAULTA SUPPORT SYSTEM
K082571 · C.R. Bard, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 25d
Cleared Sep 26, 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948 · Olympus Medical Systems Corporation
HET · Laparoscope, Gynecologic (and Accessories) · 176d
Cleared Sep 25, 2008
K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
K081236 · Mcneil-Ppc, Inc.
NUC · Lubricant, Personal · 147d
Cleared Sep 19, 2008
ICSI CUMULASE
K081639 · Medicult A/S
MQL · Media, Reproductive · 100d
Cleared Sep 17, 2008
G-MOPS G5 SERIES
K081115 · Vitrolife Sweden AB
MQL · Media, Reproductive · 152d
Cleared Sep 16, 2008
G-1 V5
K081114 · Vitrolife Sweden AB
MQL · Media, Reproductive · 151d
Cleared Sep 16, 2008
G-2 V5
K081117 · Vitrolife Sweden AB
MQL · Media, Reproductive · 151d
Cleared Sep 11, 2008
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
K082307 · Evenflo Company, Inc.
HGX · Pump, Breast, Powered · 29d

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All categories 4525 HIS Condom 401 HET Laparoscope, Gynecologic (and Accessories) 335 MQL Media, Reproductive 259 HGX Pump, Breast, Powered 254 NUC Lubricant, Personal 249 HGM System, Monitoring, Perinatal 209 HEB Tampon, Menstrual, Unscented 189 HIF Insufflator, Laparoscopic 177 HIH Hysteroscope (and Accessories) 173 HHD Pad, Menstrual, Unscented 136 LKF Cannula, Manipulator/injector, Uterine 87 HIL Tampon, Menstrual, Scented, Scented-deodorized 84 HIB Speculum, Vaginal, Nonmetal 72 HHT Spatula, Cervical, Cytological 70 KNA Instrument, Manual, Specialized Obstetric-gynecologic 58